The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea

NCT ID: NCT03745898

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2022-06-17

Brief Summary

The purpose of this trial is to evaluate the long-term effects of Nocturnal Oxygen Therapy (NOXT) on the mortality and morbidity of patients with stable heart failure and a reduced ejection fraction (HFrEF), already receiving optimal guideline-directed medical therapy (GDMT), who have central sleep apnea (CSA).

Conditions

Heart Failure; Central Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Nocturnal Oxygen Therapy

Active nocturnal oxygen therapy

Group Type: ACTIVE_COMPARATOR

Oxygen

Intervention Type: DRUG

Active nocturnal oxygen concentrator

Sham Nocturnal Oxygen Therapy

Sham nocturnal oxygen therapy (room air)

Group Type: SHAM_COMPARATOR

Room Air

Intervention Type: OTHER

Sham nocturnal oxygen concentrator (room air)

Interventions

Oxygen

Active nocturnal oxygen concentrator

Intervention Type: DRUG

Room Air

Sham nocturnal oxygen concentrator (room air)

Intervention Type: OTHER

Other Intervention Names

Sham Oxygen

Eligibility Criteria

Inclusion Criteria

• Aged ≥ 21 years at the date of consent.
• History of chronic, stable heart failure with reduced ejection fraction with left ventricular ejection fraction (LVEF) ≤ 50% determined by echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging, within the year prior to enrollment.
• Central sleep apnea, defined using as an apnea-hypopnea index (AHI) > 15/h with ≥ 50% central events (apnea and hypopneas).
• New York Heart Association (NYHA) Class III or IV, or NYHA Class II with any of the following:

1. at least one hospitalization for heart failure within the 24 months prior to enrollment or;

2. a BMI corrected BNP ≥ 300 pg/ml or a corrected NT-proBNP ≥ 1500 pg/ml or;

3. an ED visit for HF exacerbation where the patient has received an IV diuretic within 12 months of enrollment.

• Treatment with stable, optimized guideline-directed medical therapies (GDMT) according to applicable guidelines in the U.S. and Canada, where stable is defined as the addition of no new class of disease-modifying drug for ≥ 30 days prior to randomization (reasons for intolerance to GDNT must be documented).
• In the investigator's opinion, willing and able to comply with all study requirements.
• Able to fully understand study information and sign an Institutional Review Board (IRB) approved informed consent (including HIPAA authorization in the U.S.).

Exclusion Criteria

• Current positive airway pressure use or predominantly obstructive rather than central sleep apnea.
• Oxygen saturation < 90% at rest during the day.
• Nocturnal oxygen saturation < 88% for > 5 continuous minutes unaccompanied by apneas or hypopneas.
• Chronic daytime or nighttime use of supplemental oxygen.
• Participants and their bed-partners who currently smoke in the bedroom.
• Severe pulmonary disease requiring continuous home oxygen therapy or the continuous or frequent intermittent use of oral steroids or documented severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) < 50%.
• Cardiac surgery, percutaneous coronary intervention, myocardial infarction or unstable angina within the previous 3 months.
• Transient ischemic attack or stroke within the previous 3 months.
• Cardiac resynchronization therapy implantation scheduled or performed within 3 months prior to randomization.
• Primary hemodynamically-significant uncorrected valvular heart disease (obstructive or regurgitant) or any valvular disease expected to require surgery during the trial.
• Acute myocarditis/pericarditis or other cause of potentially reversible cardiomyopathy (e.g., post-partum cardiomyopathy, tachycardia-induced cardiomyopathy), within the previous 6 months.
• End-stage (Stage D) heart failure (HF) requiring continuous outpatient intravenous (IV) inotropic therapy, placement of ventricular assist device, listing for cardiac transplantation, or end-of-life care (e.g. hospice care).
• Pregnancy or of child bearing potential without a negative pregnancy test within 10 days prior to enrollment.
• Life expectancy < 1 year for diseases unrelated to chronic HF.
• Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound subject results in this trial.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Susan Redline

Professor and Senior Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Arizona

Tucson, Arizona, United States

Stanford University

Stanford, California, United States

Yale School of Medicine

New Haven, Connecticut, United States

University of Miami

Coral Gables, Florida, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Saint Luke's Mid America Health Institute

Kansas City, Kansas, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Wayne State University

Detroit, Michigan, United States

Washington University in St. Louis

St Louis, Missouri, United States

University of New Mexico School of Medicine

Albuquerque, New Mexico, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

University Hospitals

Highland Hills, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Main Line Health

Wynnewood, Pennsylvania, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

University of Washington

Seattle, Washington, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U24HL140412-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U24HL140412-01_UG3

Identifier Type: -

Identifier Source: org_study_id